Usual Adult Dose for Congestive Heart Failure

Initial dose: 5 mg orally twice a day with meals
Maximum dose: 7.5 mg orally twice a day

Comments:

• In patients with a history of conduction defects or in patients whom bradycardia could lead to hemodynamic compromise, start with 2.5 mg orally twice a day.
• Assess after 2 weeks and adjust dose to maintain tolerability and achieve resting heart rate between 50 and 60 beats per minute (bpm); if resting heart rate is greater than 60 bpm, increase by 2.5 mg twice daily to a maximum of 7.5 mg twice daily; if resting heart rate is less than 50 bpm or bradycardia signs and symptoms occur, decrease by 2.5 mg twice daily (discontinue if current dose is 2.5 mg orally twice a day).

Use: To reduce worsening heart failure hospitalization risk in patients with stable, symptomatic chronic heart failure and left ventricular ejection fraction (LVEF) at or below 35%, who are in sinus rhythm with resting heart rate at or above 70 bpm and are either unable to tolerate or have a contraindication to beta-blockers.

Usual Pediatric Dose for Congestive Heart Failure

6 Months or Older:
Less than 40 kg (oral solution):

• Initial dose: 0.05 mg/kg orally twice a day with food; assess patient at 2-week intervals and adjust dose by 0.05 mg/kg to target a heart rate reduction of at least 20%, based on tolerability.
• Maximum dose: 6 months to less than 1 year old: 0.2 mg/kg orally twice a day, up to a total of 7.5 mg orally twice a day; 1 year or older: 0.3 mg/kg orally twice a day, up to a total of 7.5 mg orally twice a day.

40 kg or more (tablets):

• Initial dose: 2.5 mg orally twice a day with food; assess patient at 2-week intervals and adjust dose by 2.5 mg to target a heart rate reduction of at least 20%, based on tolerability.
• Maximum dose: 7.5 mg orally twice a day

Use: Treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients 6 months or older who are in sinus rhythm with an elevated heart rate.

Renal Dose Adjustments

CrCl 15 to 60 mL/min: No adjustment recommended
CrCl less than 15 mL/min: Data not available

Liver Dose Adjustments

Mild to moderate liver dysfunction: No adjustment recommended
Severe liver dysfunction (Child-Pugh C): Contraindicated

Dose Adjustments

Pediatric patients:

• If bradycardia occurs, reduce the dose to the previous titration step; if bradycardia occurs at the recommended initial dose, consider reducing the dose to 0.02 mg/kg orally twice a day.

Precautions

Safety and efficacy have not been established in patients younger than 6 months.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Take with meals.
• Do not give another dose to make up for a missed or spit out dose of the oral solution. Give the next dose at the usual time.
• In pediatric patients weighing 40 kg or more who are unable to swallow tablets, the oral solution can be used instead of tablets.

Reconstitution/preparation techniques:

• Oral solution: Empty the entire contents of the ampule(s) into a medication cup. With a calibrated oral syringe, measure the prescribed dose from the medication cup. Discard any unused oral solution.

Monitoring:

• Monitor cardiac rhythm regularly.
• Monitor heart rate decreases and bradycardia symptoms.

Patient advice:

• Apprise pregnant women of the potential risks to a fetus.
• Instruct females of reproductive potential to use effective contraception and to notify their healthcare provider with a known or suspected pregnancy.
• Encourage patients to report significant decreases in heart rate or symptoms such as dizziness, fatigue, or hypotension.
• Notify patients to report symptoms of atrial fibrillation such as heart palpitations or racing, chest pressure, or worsened shortness of breath.
• Advise patients of the possible occurrence of luminous phenomena (phosphenes) and to use caution if they are driving or using machines in situations where sudden changes in light intensity may occur, especially when driving at night.
• Advise parents/caregivers regarding the preparation and administration of the oral solution.